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SX-682 + Nivolumab for Pancreatic Cancer
Phase 1
Recruiting
Led By Richard Dunne, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Completion of at least 16 weeks of first line chemotherapy without evidence of disease progression
Must not have
Subjects with clinically significant heart disease that affects normal activities
History of myelodysplastic syndromes or myeloproliferative neoplasms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of enrollment until date of death from any cause up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug combo to see what the max dose is that patients can tolerate while still benefiting from the treatment.
Who is the study for?
This trial is for adults over 18 with metastatic pancreatic ductal adenocarcinoma who've completed at least 16 weeks of first-line chemo without the cancer getting worse. They must be able to perform daily activities (ECOG status 0 or 1) and not have brain metastases, active pneumonitis, recent major surgery, other cancers in the last three years, or use immunosuppressants. Participants need functioning organs and can't be pregnant or breastfeeding.
What is being tested?
The study tests SX-682 combined with Nivolumab as a maintenance therapy to find the highest dose patients can tolerate. It's for those whose disease didn't progress after initial chemotherapy. The goal is to see how well they handle this combination treatment and what effects it has on their cancer.
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in various organs, potential liver function changes, fatigue, skin issues, digestive disturbances, hormonal imbalances due to immune system interference by Nivolumab and SX-682.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I completed 16 weeks of initial chemotherapy without my cancer getting worse.
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My cancer is a type of pancreatic cancer that has spread.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have heart disease that limits my daily activities.
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I have a history of blood disorders like MDS or MPN.
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I had major surgery less than 4 weeks ago.
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I am on steroids or other drugs that affect my immune system.
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I have not had any cancer, except for treatable local cancers, in the last 3 years.
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I have cancer that has spread to my brain or its coverings.
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I have a serious heart or brain blood vessel condition.
Select...
I am not using herbal treatments for my condition.
Select...
I haven't had immunotherapy or experimental drugs in the last 4 weeks.
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I have a history of long QT syndrome.
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I have lung disease or had lung inflammation treated with steroids.
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I have lung inflammation that is not caused by an infection.
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I have had Hepatitis B or C.
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I have active tuberculosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of enrollment until date of death from any cause up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of enrollment until date of death from any cause up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerable dose [Safety and Tolerability]
Secondary study objectives
Overall Survival
Progression Free Survival
Side effects data
From 2023 Phase 1 & 2 trial • 12 Patients • NCT0457458367%
Neutrophil count decreased
67%
Oral hemorrhage
67%
Injection site reaction
67%
Lipase increased
67%
White blood cell decreased
67%
Anemia
67%
Fatigue
33%
Abdominal pain
33%
Edema limbs
33%
Hypokalemia
33%
Lymphocyte count decreased
33%
Memory impairment
33%
Nausea
33%
Upper gastrointestinal hemorrhage
33%
Rectal hemorrhage
33%
Flu like symptoms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301
Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301
Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: SX-682 and NivolumabExperimental Treatment2 Interventions
SX-682 Dose: 25, 50, 100, 200, 400mg BID taken as an oral pill
Nivolumab Dose: 240mg, every 2 weeks via intravenous infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SX-682
2020
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Syntrix Biosystems, Inc.Industry Sponsor
13 Previous Clinical Trials
787 Total Patients Enrolled
University of RochesterLead Sponsor
872 Previous Clinical Trials
550,077 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,696 Previous Clinical Trials
4,099,051 Total Patients Enrolled
Richard Dunne, MD5.01 ReviewsPrincipal Investigator - University of Rochester Wilmot Cancer Center
University of Rochester
2 Previous Clinical Trials
88 Total Patients Enrolled
Richard DunnePrincipal InvestigatorUniversity of Rochester Wilmot Cancer Center
3 Previous Clinical Trials
85 Total Patients Enrolled
Daniel Mulkerin, MDPrincipal InvestigatorUniversity of Rochester Wilmot Cancer Center
3 Previous Clinical Trials
161 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart disease that limits my daily activities.You have had a serious allergic reaction to a specific type of medication called a monoclonal antibody in the past.Your EKG shows that your heart's QTc interval is longer than 470 milliseconds.You have had a severe allergic reaction (anaphylaxis) or have uncontrolled asthma.I have a history of blood disorders like MDS or MPN.I had major surgery less than 4 weeks ago.I (or my proxy) have signed the consent forms for the study and biomarker tests.I am on steroids or other drugs that affect my immune system.I am fully active or can carry out light work.You have an ongoing autoimmune disease.Women must have a negative pregnancy test within 24 hours before starting the study drug.I have not had any cancer, except for treatable local cancers, in the last 3 years.I am willing and able to follow the study's schedule and requirements.I have cancer that has spread to my brain or its coverings.I am a woman under 62 and have a confirmed FSH level over 40, indicating I am postmenopausal.I have a serious heart or brain blood vessel condition.I am not using herbal treatments for my condition.I am a man and will use highly effective birth control during and for 7 months after the study.I haven't had immunotherapy or experimental drugs in the last 4 weeks.I haven't taken any experimental drugs or high-dose immune-suppressing medications in the last 28 days.I completed 16 weeks of initial chemotherapy without my cancer getting worse.I am 18 years old or older.Before starting the study drug, your recent blood tests should show certain levels for white blood cells, neutrophils, platelets, hemoglobin, creatinine, liver enzymes, and blood clotting factors.I have a history of long QT syndrome.My cancer is a type of pancreatic cancer that has spread.You must have a measurable disease with at least one lesion that can be measured.I have lung disease or had lung inflammation treated with steroids.I have lung inflammation that is not caused by an infection.I have had Hepatitis B or C.I am using highly effective birth control during and for 5 months after the study.I have active tuberculosis.Before the trial, your oxygen level must be at least 90% when measured with a pulse oximeter while breathing regular air.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: SX-682 and Nivolumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.